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NIRAF-Guided Parathyroid Identification During Thyroidectomy

29 mai 2026 mis à jour par: Prof. Magdalena Bogdanovska Todorovska, Ss. Cyril and Methodius University of Skopje

Near-Infrared Autofluorescence-Guided Parathyroid Identification During Thyroidectomy

This is a single-site, two-component prospective study evaluating whether near-infrared autofluorescence (NIRAF) imaging can improve intraoperative identification of parathyroid glands during thyroidectomy and reduce postoperative hypocalcemia.

The investigational platform is a modified wearable stereoscopic goggle system configured for label-free NIRAF imaging. Parathyroid tissue is excited with near-infrared light at approximately 780 nm and emits autofluorescence centered near 800 nm. No injected dye or external contrast agent is used. The goggles are used only during a brief mapping interval after thyroid exposure and for ex vivo interrogation of the resected thyroid specimen.

Component A is a prospective observational run-in validation cohort of 30 adults undergoing thyroidectomy of any extent. NIRAF-positive foci on the intact thyroidectomy specimen are suture-marked and correlated with targeted pathology.

Component B is a randomized clinical study of 250 adults undergoing total or completion thyroidectomy. Participants are randomized 1:1 to standard surgery or standard surgery plus brief in vivo NIRAF mapping, ex vivo specimen interrogation, and rescue autotransplantation when indicated. The primary outcome for Component B is transient biochemical hypocalcemia on postoperative day 1, defined using albumin-corrected serum calcium.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Near-infrared autofluorescence (NIRAF) imaging is being evaluated as a structured adjunct to standard thyroidectomy for localization and preservation of parathyroid tissue. Parathyroid tissue emits intrinsic near-infrared autofluorescence without administration of dye or other contrast agent. The study imaging platform is a modified head-mounted stereoscopic goggle system that provides near-infrared excitation at approximately 780 nm and detects autofluorescence centered near 800 nm. Imaging is non-contact and is performed only during a brief prespecified in vivo mapping interval and ex vivo back-table specimen interrogation.

The study includes a run-in validation component followed by a randomized interventional component. In the run-in component, ex vivo imaging of thyroidectomy specimens is used to standardize imaging conditions, documentation, suture marking, specimen mapping, and pathology correlation for NIRAF-positive foci. In the randomized component, participants undergoing total or completion thyroidectomy are randomized to standard surgery or standard surgery plus adjunct NIRAF mapping. In the intervention arm, the surgeon records parathyroid glands identified under white light before mapping, then uses NIRAF information as an adjunct to standard anatomy and surgical judgment. After thyroid removal, ex vivo specimen imaging may be used to identify NIRAF-bright foci that could represent inadvertently excised parathyroid tissue. Rescue autotransplantation may be performed only when clinically appropriate and oncologically safe.

NIRAF findings are intended to supplement, not replace, standard operative assessment, surgical anatomy, pathology review, or oncologic decision-making.

Type d'étude

Interventionnel

Inscription (Estimé)

280

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Macédoine du Nord
      • Skopje, Macédoine du Nord, 1000
        • University Clinic Hospital
        • Contact:
        • Chercheur principal:
          • Magdalena Bogdanovska Todorovska, MD, PhD
        • Sous-enquêteur:
          • Borislav Kondov, MD, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age 18 years or older.
  • For Component A: planned thyroidectomy of any extent with an intact specimen available for ex vivo evaluation.
  • For Component B: planned total or completion thyroidectomy.
  • Ability to provide written informed consent before surgery.
  • Willingness to comply with routine postoperative laboratory testing and follow-up when feasible.

Exclusion Criteria:

  • Known pre-existing hypoparathyroidism or prior parathyroid surgery.
  • Severe chronic kidney disease or end-stage renal disease expected to substantially confound calcium and parathyroid hormone interpretation, as defined by the site investigator.
  • Pregnancy.
  • For Component B only: gross nodal disease or a surgical plan requiring extensive nodal packet dissection in the current study phase.
  • Any condition that, in the judgment of the investigator, would make participation unsafe or compromise protocol adherence.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Standard Thyroidectomy
Participants undergo standard thyroidectomy under white light and routine surgical judgment. Conventional autotransplantation remains permitted if the surgeon identifies a devascularized or inadvertently excised parathyroid gland by standard methods.
Expérimental: Standard Thyroidectomy Plus NIRAF-Guided Parathyroid Mapping
Participants undergo standard thyroidectomy plus a defined interval of in vivo near-infrared autofluorescence (NIRAF) mapping after thyroid exposure and ex vivo interrogation of the resected thyroid specimen. Rescue autotransplantation may be performed when a NIRAF-bright focus on the specimen is judged likely to represent parathyroid tissue and meets predefined oncologic safety criteria.
Dispositif: Wearable Near-Infrared Autofluorescence Imaging System
A modified Meta head-mounted stereoscopic goggle system configured for label-free near-infrared autofluorescence imaging. The system delivers near-infrared excitation at approximately 780 nm and detects parathyroid autofluorescence centered near 800 nm. No injected dye or external contrast agent is administered. The device is used briefly after thyroid exposure for in vivo mapping and after thyroid resection for ex vivo specimen interrogation.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Postoperative Day 1 Biochemical Hypocalcemia
Délai: Postoperative Day 1
Proportion of randomized Component B participants with transient biochemical hypocalcemia on postoperative day 1, defined as albumin-corrected total serum calcium below the lower limit of the institutional clinical laboratory reference range in use at study activation.
Postoperative Day 1

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Early Intact Parathyroid Hormone
Délai: 2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1
Early intact parathyroid hormone concentration used as an acute physiologic correlate of in situ parathyroid gland function.
2 to 4 hours postoperatively, with optional assessment on Postoperative Day 1
Mapping Yield
Délai: Intraoperative
Number of parathyroid-consistent NIRAF sites identified during the intraoperative mapping interval.
Intraoperative
Additional NIRAF Sites Beyond White-Light Assessment
Délai: Intraoperative
Number of NIRAF sites identified that were not included in the surgeon's pre-mapping white-light declaration.
Intraoperative
Mapping Efficiency
Délai: Intraoperative
Time to first parathyroid identification with NIRAF imaging and total duration of the intraoperative mapping interval.
Intraoperative
Incidental Parathyroid Tissue in the Thyroidectomy Specimen
Délai: Postoperative pathology review (up to 30 days postoperatively)
Presence and number of histologically confirmed parathyroid glands or parathyroid tissue fragments identified in the thyroidectomy specimen, including size when feasible. The number of confirmed parathyroid glands or tissue foci may be summarized categorically as 0, 1, 2, 3, or 4 when applicable.
Postoperative pathology review (up to 30 days postoperatively)
Rescue Autotransplantation Events
Délai: Intraoperative
Whether rescue autotransplantation was performed, including tissue source, implant site, and number of fragments implanted.
Intraoperative
Longer-Term Albumin-Corrected Serum Calcium
Délai: Postoperative week 8 and postoperative month 6
Albumin-corrected total serum calcium concentration measured at postoperative follow-up.
Postoperative week 8 and postoperative month 6
Longer-Term Intact Parathyroid Hormone
Délai: Postoperative week 8 and postoperative month 6
Serum intact parathyroid hormone concentration measured at postoperative follow-up.
Postoperative week 8 and postoperative month 6
Calcium or Calcitriol Supplementation at Follow-Up
Délai: Postoperative week 8 and postoperative month 6
Use of oral calcium and/or calcitriol supplementation at postoperative follow-up.
Postoperative week 8 and postoperative month 6

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ss. Cyril and Methodius University of Skopje

Collaborateurs

University of Illinois at Urbana-Champaign

Les enquêteurs

  • Chercheur principal: Magdalena Bogdanovska Todorovska, MD, PhD, Ss. Cyril and Methodius University of Skopje

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2029

Achèvement de l'étude (Estimé)

1 décembre 2029

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité

29 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 02-2848/10

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

No individual participant data will be shared with outside researchers. Deidentified aggregate study results may be reported in scientific presentations and publications.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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